tangis - Anterior Cervical Plating System, 4.25mm dia. - NVISION BIOMEDICAL TECHNOLOGIES, INC.

Duns Number:047486041

Device Description: Anterior Cervical Plating System, 4.25mm dia. 12mm long fixed screw. The Tangis Anterior Anterior Cervical Plating System, 4.25mm dia. 12mm long fixed screw. The Tangis Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. Itis to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis

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More Product Details

Catalog Number

ACP-425-12F

Brand Name

tangis

Version/Model Number

ACP-425-12F

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K161524

Product Code Details

Product Code

KWQ

Product Code Name

Appliance, Fixation, Spinal Intervertebral Body

Device Record Status

Public Device Record Key

651bcafe-9f83-4da3-8ff9-feb0dce11700

Public Version Date

January 20, 2020

Public Version Number

6

DI Record Publish Date

February 28, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NVISION BIOMEDICAL TECHNOLOGIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 461
2 A medical device with a moderate to high risk that requires special controls. 1046